ALISO VIEJO, Calif.--(BUSINESS WIRE)--Jun 8, 2007 - AVANIR
Pharmaceuticals (NASDAQ:AVNR) today announced the presentation of
Phase III data, including efficacy, safety and improvements in
patient-centered outcomes in patients with diabetic peripheral
neuropathic (DPN) pain treated with the investigational drug
Zenvia(TM) (dextromethorphan/quinidine (DM/Q)), an NMDA receptor
antagonist and sigma-1 agonist. The data were accepted as
'late-breakers' and presented in two posters at the Second
International Congress on Neuropathic Pain (ICNP) in Berlin.

DPN pain is a common complication of diabetes that has
significant impact on outcomes of concern to patients including
sleep, activity and quality of life. In a multi-center, 3-month,
double-blind Phase III trial, active treatment with Zenvia 45/30 mg
dosed twice daily (DM/Q 45) and 30/30 mg DM/Q dosed twice daily
(DM/Q 30) over a three month period, was compared to placebo.
AVANIR previously announced in April 2007 that both doses of Zenvia
had met the primary endpoint of statistically significant
improvements versus placebo as recorded in daily patient diary
entries using the Pain Rating Scale, as defined in the Special
Protocol Assessment (SPA) with the U.S. Food and Drug
Administration (FDA). In addition the DM/Q 45 met statistical
significance for 4 out of 5 secondary endpoints reported.

-- 28% of patients in the DM/Q 45 arm and 27% in the DM/Q 30 arm
obtained "a lot" of or "complete" pain relief at three months
versus 17% in the placebo group (p=0.0008 and p=0.0017
respectively)

-- Active treatment with both Zenvia doses significantly reduced
pain interference with
daily activities (p less than 0.0001), and
sleep (p less than 0.0001) compared with placebo.

-- The magnitude of the improvements in quality-of-life with
Zenvia treatment was approximately 50% greater than that obtained
with placebo (p=0.05 for DM/Q 45 and p=0.08 for DM/Q 30).

-- QTc interval mean change was 5 and 2 milliseconds in the DM/Q
45 and DM/Q 30 treatment groups, respectively compared to the
screening visit, versus a mean change in QTc interval of -2
milliseconds for placebo at day 92.

-- There were no cases of Torsade de Pointes (a life-threatening
condition) or sudden death reported.

"The Phase III trial data indicate that both doses of Zenvia
demonstrated significantly superior reduction of pain compared with
placebo in patients with DPN pain. Additionally, Zenvia was
generally safe and well tolerated, and safety data were consistent
with previous clinical studies with no new safety signals noted,"
said study investigator Aziz Shaibani, MD, FACP, Clinical Assistant
Professor, Department of Medicine, Baylor College of Medicine,
Houston, Texas.

"Based on the data from this study, we conclude that Zenvia
provides significantly greater improvements compared with placebo
in pain-related outcomes in patients with DPN pain, including pain
relief, activity and sleep. These are important outcomes to
patients suffering from daily pain as a complication of their
diabetes," stated Randall Kaye, MD, Chief Medical Officer of AVANIR
Pharmaceuticals.

-- Treatment with Zenvia resulted in a more rapid and marked
reduction in pain scores relative to placebo, with a trend toward
greater pain reduction at the higher dose.

-- Both active treatment groups had lower pain ratings than
placebo patient
s (p less than 0.0001 for both comparisons),
demonstrating significantly greater reductions in pain compared
with placebo. Pain score averaged over the study periods were
significantly lower than placebo in the DM/Q 45 arm for comparisons
at days 30, 60 and 90 (p less than 0.0001 for each comparison) and
in the DM/Q 30 arm (p less than 0.0001 at days 30 and 60, p=0.0071
at day 90). The consistency in the magnitude of response suggests
that the pain reduction obtained with active treatment relative to
placebo were maintained over the entire study duration.

-- Improvements from baseline with active treatment appeared to
be dose dependent, with the higher dose resulting in improvements
that were almost twice as great as placebo.

-- Both doses demonstrated significantly better improvements in
pain from baseline that were maintained over the duration of the
study.

-- The incidence of AEs was higher in the DM/Q 45 group (91%),
compared with placebo (80%) and DM/Q 30 (79%), with the proportion
of patients discontinuing due to an AE higher in both active
treatments compared with placebo.

-- The most common AEs were dizziness, nausea, diarrhea, fatigue
and somnolence and were generally mild to moderate in severity.

-- There were no statistically significant differences in
serious adverse event rates reported in the DM/Q 45, DM/Q 30 and
placebo groups, and no deaths occurred during the study.

-- Both Zenvia doses were significantly superior to placebo in
relieving pain. The pattern reported in the Pain Relief Scale
complemented that shown by the Pai
n Rating Scale scores over the
same time period as reported in the primary efficacy analysis.

-- Categorical analysis of the Pain Relief Rating Scale scores
averaged at three months showed that almost twice as many patients
in each of the Zenvia treatment groups obtained "a lot" of or
"complete" pain relief as that in the placebo group.

-- Active treatment with both Zenvia doses significantly reduced
pain interference with sleep compared with placebo (p less than
0.0001).

-- The consistency for reduced pain interference with both daily
activities and reduced sleep interference across time periods
during the study suggests that the benefits of Zenvia relative to
placebo were maintained over the entire study period.

-- The magnitude of the improvements in quality-of-life with
Zenvia was approximately 50% greater than that obtained with
placebo (p=0.05 for DM/Q 45 and p=0.08 for DM/Q 30).

Cardiovascular findings were assessed by EKGs at screening, as
well as clinical visits at day 1, 15 and 92. At day 15 the mean
change in QTc interval compared to the screening visit was 1
millisecond in both treatment groups, versus a mean change in QTc
interval of -2 milliseconds for placebo. At day 92 the mean change
in QTc intervals was 5 and 2 milliseconds in the DM/Q 45 and DM/Q
30 treatment groups, respectively compared to the screening visit,
versus a mean change in QTc interval of -2 milliseconds for
placebo. These increases were consistent with what has been
observed in previous studies. There were no cases of Torsade de
Pointes or sudden death reported. The most commonly reported
adverse events from this Phase III study were dizziness, nausea,
diarrhea, fatigue and somnolence which were mild to moderate in
nature. A higher number of patients in the DM/Q 45 and DM/Q 30
treatment groups (2
5.2% and 21.0%, respectively) discontinued due
to an adverse event than compared to placebo (11.4%). There were no
statistically significant differences in serious adverse event
rates with 7.6%, 4.8% and 4.1% reported in the DM/Q 45, DM/Q 30 and
placebo groups, respectively, and no deaths occurred during the
study.

For more details, a PDF version of each poster can be found at
the Company's website (www.avanir.com).

About Diabetic Neuropathic Pain

Diabetic neuropathic pain, one of the most debilitating forms of
pain, is caused by nerve damage that can result from diabetes. It
is often described as burning, tingling, stabbing, or pins and
needles in the feet, legs, hands or arms. An estimated 3.5 million
people in the United States experience diabetic neuropathic pain
according to the American Diabetes Association.

About Zenvia

Zenvia is a combination of two well-characterized compounds, the
therapeutically active ingredient dextromethorphan, and the enzyme
inhibitor quinidine, which serves to increase the bioavailability
of dextromethorphan. This first-in-class drug candidate is believed
to help regulate excitatory neurotransmission in two ways, through
pre-synaptic inhibition of glutamate release via sigma-1 receptor
agonist activity, and through postsynaptic glutamate response
modulation via uncompetitive, low-affinity NMDA antagonist
activity. Zenvia is currently in development for the treatment of
Involuntary Emotional Expression Disorder (IEED) and DPN pain.

In October 2006, the Company received an approvable letter for
the treatment of Zenvia in IEED. To address safety concerns raised
in the FDA's approvable letter for Zenvia for the treatment of
IEED, the company intends to initiate a confirmatory Phase III
study with a new lower quinidine dose formulation of Zenvia. In
April 2007 AVANIR completed a Phase III study in patients with
diabetic peripheral neuropathic pain where all primary endpoints
were successfully met.
The Company is considering whether it would
be necessary or advisable to study a similar lower dose of
quinidine in a second Phase III trial being planned for DPN
pain.

About AVANIR

AVANIR Pharmaceuticals is focused on developing, acquiring and
commercializing novel therapeutic products for the treatment of
chronic diseases. AVANIR's products and product candidates address
therapeutic markets that include the central nervous system,
cardiovascular disorders, inflammation and infectious diseases.
AVANIR currently markets FazaClo(R), the only orally-disintegrating
formulation of clozapine for the management of severely ill
schizophrenic patients who fail to respond adequately to standard
drug treatments for schizophrenia. FazaClo is also indicated for
reducing the risk of suicidal behavior in patients with
schizophrenia or schizoaffective disorder. For full prescribing
information and important safety information regarding FazaClo,
please visit www.fazaclo.com. AVANIR's lead product candidate for
the treatment of involuntary emotional expression disorder (IEED),
Zenvia, is the subject of an approvable letter from the FDA.
Additionally, AVANIR recently completed a Phase III clinical trial
with Zenvia in patients with diabetic peripheral neuropathic (DPN)
pain where all primary endpoints were met. AVANIR has an ongoing
development program with Novartis International Pharmaceutical Ltd.
for the treatment of inflammatory disease. The Company's first
commercialized product, Abreva(R), is marketed in North America by
GlaxoSmithKline Consumer Healthcare and is the leading
over-the-counter product for the treatment of cold sores. Further
information about AVANIR can be found at www.avanir.com.

Forward Looking Statement

Statements in this press release that are not historical facts,
including statements that are preceded by, followed by, or that
include such words as "estimate," "intend," "anticipate,"
"believe," "plan," "goal," "expect," or simila
r statements, are
forward-looking statements that are subject to certain risks and
uncertainties that could cause actual results to differ materially
from the future results expressed or implied by such statements.
There can be no assurance that the Company will receive FDA
regulatory approval for Zenvia for any indication or that the
additional development work for Zenvia will be completed in the
time periods that are anticipated. Final review decisions made by
the FDA and other regulatory agencies concerning the Company's
products and product candidates are often unpredictable and outside
the influence and control of the Company, and it is possible that
the FDA could disagree with the Company's interpretation of
clinical trial results. Risks and uncertainties also include the
risks set forth in AVANIR's most recent Annual Report on Form 10-K
and subsequent Quarterly Reports on Form 10-Q, and from
time-to-time in other publicly available information regarding the
Company. Copies of this information are available from AVANIR upon
request. AVANIR disclaims any intent to update these
forward-looking statements.

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below or visit AVANIR's website:
http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0.

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